Regulatory Affairs Specialist
Job in
Fall River, Bristol County, Massachusetts, 02720, USA
Listed on 2026-07-14
Listing for:
United Consulting Hub
Full Time
position Listed on 2026-07-14
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Job Title
:
Regulatory Affairs Specialist
Location
: MA — Hybrid (3 Days Onsite)
Employment Type
:
Contract (W2 Only)
We are seeking a Regulatory Affairs Specialist to support regulatory submissions, product documentation, and compliance activities for pharmaceutical or medical device products.
Key Responsibilities- Assist with preparation and maintenance of regulatory submissions
- Support product registrations and regulatory documentation
- Maintain technical files and regulatory records
- Assist with labeling reviews and product change assessments
- Support regulatory impact assessments for change controls
- Monitor regulatory requirements and assist with compliance activities
- Collaborate with Quality, Clinical, R&D, and Manufacturing teams
- Bachelor's degree in Regulatory Affairs, Pharmacy, Life Sciences, Biomedical Engineering, or related field
- 0–3 years of Regulatory Affairs or regulated industry experience
- Basic knowledge of FDA regulatory requirements
- Strong writing, communication, and organizational skills
- Familiarity with FDA submissions, eCTD, or technical documentation
- Knowledge of ISO 13485 or EU MDR is a plus
- Experience with document management systems is preferred
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